The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3 fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial with children ages 5-12 years old with bipolar spectrum disorders.

Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.

Other Name: ProOmega Junior

Active Comparator: Placebo/Inositol

Combination Placebo and Inositol treatment.

Drug: Inositol

Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.

Active Comparator: Omega-3/Inositol

Combination Omega-3 and Inositol treatment.

Drug: Omega-3

Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.

Other Name: ProOmega Junior

Drug: Inositol

Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.

Eligibility

Ages Eligible for Study:

5 Years to 12 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female subjects, 5-12 years of age.

Subjects must have a DSM-IV diagnosis of bipolar spectrum disorder (types I, II, and not otherwise specified) and currently be displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and structured diagnostic interview (Kiddie Schedule of Affective Disorders and Schizophrenia Epidemiological Version, Orvaschel, 1994).

Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.

Subjects and their legal representative must be considered reliable.

Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.

Subjects must have an initial total score on the YMRS of at least 20.

Subject must be able to participate in mandatory blood draws.

Subject must be able to swallow pills.

Subjects with ADHD, ODD, conduct disorder, and anxiety will be allowed to participate in the study provided that the impairment associated with these disorders is of a lesser degree of severity relative to the impairment of the bipolar disorder, according to clinician evaluation.

History of bleeding diathesis, including those with von Willebrand disease.

Uncorrected hypothyroidism or hyperthyroidism.

History of sensitivity to omega-3 fatty acids or inositol. A non-responder or history of intolerance to omega-3 or inositol, after 2 months of treatment at adequate doses as determined by the clinician.

Severe allergies or multiple adverse drug reactions.

Failed 2 or more previous trials with anti-manic treatments including lithium, anticonvulsants, and atypical antipsychotic medication.

Current or past history or seizures.

DSM-IV substance use, abuse, or dependence (unlikely in ages 5-12).

Judged clinically to be at serious suicidal risk.

Any other concomitant medication with primarily central nervous system activity other than no greater than 2mg lorazepam taken no more than 3 days during the study.

Current diagnosis of schizophrenia.

Pregnancy (unlikely in ages 5-12).

Girls who have begun menstruating.

YMRS Item #8 (Content) score of 8 ("delusions; hallucinations").

YRMS total score above 40.

Girls who have begun menstruating.

C-SSRS score > 4.

IQ <70.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396486